Last updated: September 8, 2022
Sponsor: Affiliated Hospital of Nantong University
Overall Status: Active - Recruiting
Phase
4
Condition
Perimenopause
Treatment
N/AClinical Study ID
NCT05021094
AHNantong-POI
Ages 18-39 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The women aged <40 years old.
- Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twiceinspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- Individuals meeting the above criteria who voluntarily consented to studyparticipation.
Exclusion
Exclusion Criteria:
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids,endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- Patients with known or suspected breast cancer history and estrogen-dependentmalignant tumor;
- Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- Patients with porphyria;
- Patients with serious primary diseases or mental illness such as cardiovascular,liver, kidney and hematopoietic system;
- Patients who are participating in other clinical trials or have participated in otherclinical trials in the past three months;
- Patients who suspect or have a history of alcohol and drug abuse;
- Patients who are known to be allergic to the test drugs or their components;
- The researchers determined that patients are not suitable for this trial.
Study Design
Total Participants: 120
Study Start date:
October 22, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Hai'an People's Hospital
Hai'an, Jiangsu 226600
ChinaActive - Recruiting
Hai'an Hospital of traditional Chinese Medicine
Huai'an, Jiangsu 226600
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
ChinaActive - Recruiting
Nantong First People's Hospital
Nantong, Jiangsu 226001
ChinaActive - Recruiting
Nantong Hospital of Traditional Chinese Medicine
Nantong, Jiangsu 226001
ChinaActive - Recruiting
Rugao Boai Hospital
Ru'gao, Jiangsu 226500
ChinaActive - Recruiting
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